Groups of people currently under-represented in clinical trials could benefit from improved health prospects – thanks to a new toolkit that will help researchers make their investigations more inclusive and representative.
Without representative participation, clinical trials cannot accurately reflect how medical interventions impact patients – introducing bias and affecting research quality. This can result in reluctance to offer treatments to specific groups, contributing to health inequality.
Backed by NIHR Biomedical Research Centre funding, researchers at the University of Birmingham have developed the REP-EQUITY toolkit to guide representative and equitable inclusion in clinical research. The toolkit describes seven key questions for investigators to consider when recruiting people to take part in their trials.
- What are the relevant underserved groups?
- What is the aim in relation to representativeness and equity? For example, do researchers want to include participants representing the general population, or do they have particular focus on people from groups experiencing poorer health outcomes?
- How will sample proportion of individuals with underserved characteristics be defined?
- What are the recruitment goals?
- How will external factors be managed?
- How will representation be evaluated?
- What will be the legacy?
Publishing their work in Nature Medicine, the researchers note that individuals and groups can be underserved by research for several reasons – such as on the basis of demographic (age, ethnicity, gender identity), social and economic (employment, living in remote areas, educational attainment), disease-specific factors (those with rare diseases) or health status (mental health conditions, multi-morbidities, pregnancy).
Lead author Dr Ameeta Retzer from the NIHR Birmingham Biomedical Research Centre, University of Birmingham, commented: “There is a growing emphasis placed on representative inclusion in research – both by the public and research funders. It is vital that we develop a practical and evidence-based approach to capturing inclusive and representative research samples.
“We believe our new toolkit is an important contribution, building upon and complementing existing work. It will help clinical researchers to minimise bias and promote equity, whilst building consent and trust between underserved groups and research institutions. This could be a major step towards securing better and fairer health outcomes for underrepresented groups and individuals.”
This could be a major step towards securing better and fairer health outcomes for underrepresented groups and individuals.
– Dr Ameeta Retzer
Trial participant diversity
Whilst improving clinical trial participant diversity is increasingly prioritised, the COVID-19 pandemic accelerated the need to generalise research findings to groups experiencing the greatest health burden. For example, minority populations – such as Black African & Caribbean and South East Asian groups in the UK and Black, Hispanic, and Native American communities in the US – experienced disproportionate risk of severe COVID-19 complications and death, yet were underrepresented in COVID-19 research. Similarly, others including those from lower socio-economic backgrounds and pregnant people were underserved by COVID-19 research.
Developing the toolkit coincided with significant technological advances in the use of global data – using phenotype specification, systematic code-searching, iterative and clinical review, and analysis of prevalence and validation to create research cohorts that are representative of the real-world population.
The researchers plan to further validate and pilot the REP-EQUITY toolkit and track its global use – developing an evidence base to promote its usefulness and testing its use with pooled routinely collected real world data to explore equitable sampling of people from underserved groups.
Notes for editors
- The University of Birmingham is ranked amongst the world’s top institutions, its work brings people from across the world to Birmingham, including researchers and teachers and more than 8,000 international students from over 150 countries.
- ‘A toolkit for capturing a representative and equitable sample in health research’ – Ameeta Retzer, Bircan Ciytak, Foram Khatsuria, Juma El-awaisi, Isobel M Harris, Laura Chapman, Tony Kelly, Jenny Richards, Emily Lam, Philip N Newsome, and Melanie Calvert is published by Nature Medicine and features in a separate piece across the Nature
About the National Institute for Health and Care Research
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.